FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for July 2016

Posted on Wednesday, July 6 2016 at 6:19 pm by -

Not Optional: Court Rules that Biosimilar Applicants Must Always Give Commercial Marketing Notice

By: Jennifer Giordano-Coltart, Ph.D.

Yesterday, the Court of Appeals for the Federal Circuit added yet another wrinkle to the process of bringing a lower-cost biosimilar to market. In the case of Amgen Inc. v. Apotex Inc.,[1] which involves Apotex Inc.’s (Apotex) biosimilar of Amgen Inc.’s (Amgen) Neulasta® (pegfilgrastim), the Federal Circuit unanimously ruled that a biosimilar applicant must always provide 180-day pre-commercial marketing notice to the biosimilar’s reference product sponsor under the Biologics Price Competition and Innovation Act (BPCIA) regardless of whether the applicant participated in the BPCIA’s patent information exchange procedures (42 U.S.C. § 262(1)) (i.e. the patent dance).   
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